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Senior Quality Assurance Specialist
2 months ago
About the Role:
We are seeking an experienced Senior Quality Control Associate to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors. As a Senior Quality Control Associate, you will play a key role in shaping the Quality Control Department of a contract pharmaceutical manufacturing organization.
Key Responsibilities:
- Execute hands-on U/HPLC method transfer, validation, and contribute to method development (Assay, Purity & Imps methods, Cleaning methods).
- Conduct dissolution method transfer and validation, with a lesser focus on method development.
- Perform pharmacopeial methods such as IR, Appearance, pH, CU, and water content.
- Adhere to Good Manufacturing Practice (GMP) standards using a new electronic Quality System.
- Contribute to the setup of the CDS and laboratory, and actively participate in building the LIMS system.
- Write validation plans and reports, primarily for HPLC and Dissolution methodologies.
- Write stability plans and reports.
- Support activities to qualify equipment required for QC testing, ensuring compliance with current European Pharmacopoeia and ICH requirements, and participate in the calibration of analytical equipment as needed.
- Contribute to the creation and review of Plans, Methodologies, Work Instructions, and Standard Operating Procedures (SOPs).
- Hands-on contribution to building a LIMS system to transition to a paper-free lab.
Requirements:
- Educated to Degree level in a relevant scientific discipline along with a minimum of 2 years' experience in pharmaceutical sciences within GMP development.
- Experience in an analytical laboratory environment with a sound understanding of regulatory requirements.
- Familiarity with OpenLab is desired.
About SRG:
SRG is the UK number 1 recruitment company specializing in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals, and medical devices sectors. As scientists ourselves, our specialist sector knowledge and passion are second to none. We're committed to providing outstanding temporary, contract, and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
